What is mevrometostat studying for metastatic castration-sensitive prostate cancer?

Mevrometostat is being studied to see if it works better when combined with enzalutamide compared to enzalutamide alone in men with metastatic castration-sensitive prostate cancer. The study aims to find out if this combination can improve outcomes in patients who have not yet received certain prostate cancer treatments. Pfizer is leading this research to explore new options for managing this condition.

Who may be eligible for this metastatic castration-sensitive prostate cancer clinical trial?

Men aged 18 years or older with confirmed metastatic prostate cancer who have not received chemotherapy for this stage of their disease may be eligible. Participants should have good overall health with an ECOG performance status of 0 or 1 and no significant heart problems. Please review eligibility criteria for more details.

Is there any cost to participate in this metastatic castration-sensitive prostate cancer clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal expenses such as travel may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional costs that may arise during the trial.

Actively Recruiting

Phase 3

Age: 18Years +

MALE

ID07028853

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Mevrometostat (PF-06821497) With Enzalutamide in Metastatic Castration-Sensitive Prostate Cancer (MEVPRO-3)

Led by Pfizer · Updated on 2026-06-05

1000

Participants Needed

331

Research Sites

325 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the combination of the investigational drug mevrometostat (PF-06821497) with enzalutamide compared to enzalutamide alone in men with metastatic castration-sensitive prostate cancer (mCSPC) who have not previously received androgen receptor pathway inhibitors or chemotherapy in this setting. This Phase 3, randomized, double-blind, placebo-controlled study aims to determine if the combination improves outcomes in participants who have only received limited prior therapy such as androgen-deprivation therapy or first-generation antiandrogens. Participants will be randomly assigned to one of two groups: one group will receive mevrometostat (875 mg twice daily) combined with enzalutamide (160 mg once daily), while the other group will receive a placebo twice daily plus enzalutamide (160 mg once daily). The study includes a Screening Phase, Randomization, Treatment Phase, Safety Follow-up, and Long-Term Follow-up. The treatment phase may last up to approximately 4 years, with ongoing safety and long-term assessment extending beyond this period. During the study, participants will be monitored through various evaluations including scans, blood tests, and patient-reported questionnaires assessing pain and quality of life. Researchers will measure outcomes such as radiographic progression-free survival, overall survival, prostate-specific antigen response, and adverse events, among others. Follow-up will continue for several years to assess long-term effects and disease progression, ensuring comprehensive safety and efficacy data collection throughout the trial.

CONDITIONS

Brief Title

This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide Will Work Better Than Taking Enzalutamide Alone in Participants With mCSPC Who Are ARPI naïve.

Who Can Participate

Age: 18Years +

MALE

Eligibility Criteria

You may qualify if you...

Male participants aged 18 years or older at screening
Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features
Metastatic prostate cancer confirmed by positive bone scan or metastatic lesions on CT or MRI
Resolution of acute effects of prior therapy to baseline severity or Grade 1 CTCAE (except for non-safety risk adverse events)
ECOG performance status of 0 or 1

You will not qualify if you...

Any medical or psychiatric condition, including recent or active suicidal ideation/behavior, that increases risk or is judged inappropriate for the study
Clinically significant cardiovascular disease
Known or suspected brain metastasis or active leptomeningeal disease
Prior cytotoxic chemotherapy for metastatic castration-sensitive prostate cancer
Previous use of investigational products within 30 days
Use of 5-alpha reductase inhibitors within 28 days of randomization
Prior surgery without full recovery at least 28 days before randomization
Current or anticipated use of strong CYP3A4/5 inhibitors or inducers (except enzalutamide in this study)
Inadequate organ function

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to approximately 4 years

Participants receive either mevrometostat with enzalutamide or placebo with enzalutamide as oral medications taken continuously.

Regular visits according to study schedule

Safety Follow-up

Duration - Approximately 1 year

Participants are monitored for safety after the treatment phase ends.

Visits as scheduled for safety assessments

Long-Term Follow-up

Duration - Up to approximately 5 years

Participants are followed to assess long-term outcomes including survival and quality of life.

Periodic visits for long-term assessments

Trial Site Locations

Total: 331 locations

Clearview Cancer Institute (Crestwood)

Huntsville, Alabama, United States, 35801

Actively Recruiting

Clearview Cancer Institute

Huntsville, Alabama, United States, 35805

Actively Recruiting